Effects of Microtox on Facial Skin Quality, Fine Wrinkles, and Texture

Last updated: September 23, 2024
Sponsor: Kalpna Kay Durairaj, MD, FACS
Overall Status: Active - Recruiting

Phase

1

Condition

Skin Aging

Treatment

PrabotulinumtoxinA-Xvfs

IncobotulinumtoxinA

saline solution (placebo)

Clinical Study ID

NCT06604832
KDEJ24
  • Ages 18-65
  • Female

Study Summary

The goal of this split-face clinical trial is to test the efficacy of microtox in improving facial skin quality, fine wrinkles, and texture. Participants will:

  • be randomly assigned to Group A (which will receive 20 units of neuromodulator on the left side of the forehead and a placebo saline treatment on the right side) or Group B (which will receive 20 units of neuromodulator on the left side of the forehead and 20 units of a different neuromodulator brand on the right side as a comparator)

  • have one treatment session at week 0, and two live assessment visits at weeks 2 and 12

  • have their pictures taken at each visit to track progress

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Biological females, 18-65 years old, of any race and ethnic background

  • Individuals with mild to moderate facial wrinkles

  • All skin types (Fitzpatrick I-VI)

  • Willingness to participate and provide written informed consent

  • Ability to follow study instructions and likely to complete all required visits

Exclusion

Exclusion Criteria:

  • Females who are pregnant, breastfeeding, chronically using nonsteroidalanti-inflammatory drugs, have autoimmune conditions or have a known allergy to thestudy medications.

  • Previous cosmetic procedures near the forehead within the last 6 months or botulinumtoxin treatments within the last 4 months

  • Known neuromuscular disorders or a hypersensitivity to botulinum toxin

  • Significant dermatological conditions affecting the face

  • Use of medications affecting neuromuscular function or skin healing within 2 weeksprior to the beginning of study

  • Subject has a condition or is in a situation which, in the opinion of theInvestigator, may put the subject at significant risk, may confound the studyresults, or may interfere significantly with participation in the study.

Study Design

Total Participants: 20
Treatment Group(s): 3
Primary Treatment: PrabotulinumtoxinA-Xvfs
Phase: 1
Study Start date:
September 03, 2024
Estimated Completion Date:
February 28, 2025

Study Description

Twenty (20) subjects will be enrolled in the study. The subjects will have one treatment session at week 0, and two live assessment visits at weeks 2 and 12. Office visits will last approximately 2 hours. All subjects will have their photographs taken at the beginning of each visit to track progress. Photographs will be taken of the forehead in a relaxed state, with eyebrows furrowed, and with eyebrows raised. All pictures will be taken via the Quantificare LifeViz Micro and will be stored via a HIPAA-compliant server.

Subjects will be randomly assigned to one of two groups. Group A will receive 10 units of prabotulinumtoxinA-xvfs delivered intramuscularly to the corrugator supercilii on the left of the glabellar lines, 10 units of prabotulinumtoxinA-xvfs delivered intradermally (1 mm depth) to the left side of the forehead region, and a placebo saline treatment on the right side of the glabellar lines and forehead region. Group B will receive 10 units of prabotulinumtoxinA-xvfs delivered intramuscularly to the corrugator supercilii on the left of the glabellar lines, 10 units of prabotulinumtoxinA-xvfs delivered intradermally (1 mm depth) to the left side of the forehead region, and 20 units of incobotulinumtoxinA on the right side (intramuscularly in the glabellar region and intradermally in the forehead region.

100 units of botulinum toxin A will be reconstituted with 5 mL of bacteriostatic saline. After subjects have their picture taken, topical Lidocaine/Tetracaine 23%/7% ointment cream will be applied to the treatment sites. After 15 minutes of numbing, the topical anesthetic will be cleaned off with alcohol. Subjects will be asked to repeatedly furrow and raise their eyebrows to let the treating physician assess the muscle of interest. With the subject in a semi-reclined position, the treating physician will inject microboluses using a standard 30 gauge 0.5" needle.

At each visit, the treating physician will rate each subject according to the Scientific Assessment Scale of Skin Quality (SASSQ). The Global Aesthetic Improvement Scale (GAIS) will be used by the treating physician and subjects to rate aesthetic improvement at each visit after baseline. Subjects will also rate their overall aesthetic improvement and treatment satisfaction at each visit after baseline according to a 5-point scale: (1) Extremely dissatisfied, (2) Dissatisfied, (3) Slightly satisfied, (4) Satisfied, (5) Extremely satisfied. Before and after photos of treated patients will be independently evaluated by the blinded, secondary evaluator using the SASSQ scale at each time interval of photos taken.

Connect with a study center

  • K. Kay Durairaj, MD, A Medical Corp.

    Pasadena, California 91105
    United States

    Active - Recruiting

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